ROCURONIUM BROMIDE

Product NDC
51662-1546
11-digit product format
516621546
Labeler code
51662
Product ID
51662-1546_11c3882d-668d-53b1-e063-6394a90a27ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROCURONIUM BROMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA206206
Marketing category
ANDA
Marketing start
2021-07-18
Substance
ROCURONIUM BROMIDE
Active strength
50 mg/5mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ROCURONIUM BROMIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI65MW4OFHZ
Rxcui1234995

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1546-1ROCURONIUM BROMIDE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1546ROCURONIUM BROMIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 1 package rows20240220_c76d45aa-9ee2-aa65-e053-2995a90a4702.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNc76d45aa-9ee2-aa65-e053-2995a90a47022
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDc76d45aa-9ee2-aa65-e053-2995a90a47022
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYc76d45aa-9ee2-aa65-e053-2995a90a47022
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYc76d45aa-9ee2-aa65-e053-2995a90a47022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1546-1516621546015 mL in 1 VIAL, MULTI-DOSE (51662-1546-1) 5 ml2021-07-180000-00-00NoNoCurrent